Medical Policy and Coding Updates June 2021

  • Updates for both non-individual and individual plans

  • Effective September 12, 2021

    Updates to AIM Specialty Health® Clinical Appropriateness Guidelines

    Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Advanced Imaging

    Updates by section

    Advanced Imaging of the Spine

    Congenital vertebral defects

    • Added new requirement for additional evaluation with radiographs

    Scoliosis

    • Defined presurgical planning criteria
    • Added requirement for radiographs and new or progressive symptoms for postsurgical imaging

    Spinal dysraphism
    Tethered cord

    • Revised diagnostic imaging strategy to limit CT use when MRI cannot be performed
    • Added new requirement for ultrasound prior to advanced imaging for tethered cord in infants age 5 months or less

    Multiple sclerosis

    • Added new criteria for imaging in initial diagnosis of MS

    Spinal infection

    • Aligned new diagnosis and management criteria with Infectious Disease Society of America (IDSA) and University of Michigan guidelines

    Axial spondyloarthropathy

    • Added definition of inflammatory back pain
    • Added diagnostic testing radiography requirements

    Cervical injury

    • Aligned pediatric cervical trauma criteria with American College of Radiology (ACR) guidelines

    Thoracic or lumbar injury

    • Revised diagnostic imaging strategy to include radiography and limited use of MRI for a known fracture
    • Removed indication for follow-up imaging of progressively worsening pain without fracture or neurologic deficits

    Syringomyelia

    • Removed surveillance imaging indication

    Non-specific low back pain

    • Aligned pediatric low back pain criteria with American College of Radiology (ACR) guidelines

    Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Extremity Imaging

    Updates by section

    Advanced Imaging of the Extremities

    Osteomyelitis or septic arthritis
    Myositis

    • Removed CT as a follow-up to nondiagnostic MRI due to lower diagnostic accuracy of CT

    Epicondylitis and Tenosynovitis – long head of biceps

    • Removed these sections due to lack of evidence supporting imaging for this diagnosis

    Plantar fasciitis and fibromatosis

    • Removed CT as a follow-up to nondiagnostic MRI due to lower diagnostic accuracy of CT
    • Added specific conservative management requirements

    Brachial plexus mass

    • Added specific requirement for suspicious findings on clinical exam or prior imaging

    Morton’s neuroma

    • Added requirements for focused steroid injection, orthoses, and plan for surgery

    Adhesive capsulitis

    • Added requirement for planned intervention (manipulation under anesthesia or lysis of adhesions)

    Rotator cuff tear
    Labral tear – shoulder
    Labral tear - hip

    • Defined specific exam findings and updated duration of conservative management
    • Updated recurrent labral tear to meet same criteria as an initial tear (shoulder only)

    Triangular fibrocartilage complex tear

    • Added requirement for radiographs and conservative management for chronic tear

    Ligament tear – knee; meniscal tear

    • Added requirement for radiographs for specific scenarios
    • Increased duration of conservative management for chronic meniscal tears

    Ligament and tendon injuries – foot and ankle

    • Defined required duration of conservative management

    Chronic anterior knee pain including chondromalacia patella and patellofemoral pain syndrome

    • Increased duration of conservative management and specified requirement for chronic anterior knee pain

    Intra-articular loose body

    • Added requirement for mechanical symptoms

    Osteochondral lesion (including osteochondritis dissecans, transient dislocation of patella)

    • Added new requirement for radiographs

    Entrapment neuropathy

    • Excluded carpal and cubital tunnel syndromes

    Persistent lower extremity pain

    • Defined duration of conservative management
    • Excluded hip joint (addressed in other indications)

    Upper extremity pain

    • Excludes shoulder joint (addressed in other indications)
    • Revised diagnostic testing strategy to limit CT use when MRI cannot be performed or is nondiagnostic

    Knee arthroplasty, presurgical planning

    • Limited to MAKO and robotic assist arthroplasty cases

    Perioperative imaging, not otherwise specified

    • Require radiographs or ultrasound prior to advanced imaging

    Effective for dates of service on and after September 12, 2021, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Vascular Imaging

    Updates by section

    Vascular Imaging

    • Added alternative non-vascular imaging approaches, where applicable

    Hemorrhage, Intracranial

    • Specified clinical scenario for subarachnoid hemorrhage
    • Added pediatric intracerebral hemorrhage indication

    Horner’s syndrome
    Pulsatile tinnitus
    Trigeminal neuralgia

    • Removed condition management indication for  continued vascular evaluation

    Stroke/TIA
    Stenosis or occlusion (intracranial/extracranial)

    • Added acute and subacute time frames
    • Removed carotid/cardiac workup requirement for intracranial vascular evaluation
    • Added condition management specifications
    • Separated sections into anterior/posterior circulation (carotid artery and vertebral or basilar arteries, respectively)

    Pulmonary Embolism

    • Added non-diagnostic chest radiograph requirement for all indications
    • Added pregnancy-adjusted YEARS algorithm

    Peripheral Arterial Disease

    • Added new post-revascularization indication to both upper and lower extremity PAD evaluation

    Effective September 3, 2021

    Alpha1-Proteinase Inhibitors, 5.01.624

    New policy

    The following drugs have been added and may be considered medically necessary when criteria are met:

    • Aralast® NP (alpha1-proteinase inhibitor (PI) [human])
    • Glassia® (alpha1-PI [human])
    • Prolastin®-C (alpha1-PI [human])
    • Zemaira® (alpha1-PI [human])
      • Treatment of adults with emphysema due to hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency)

    Drugs for Rare Diseases, 5.01.576

    New drugs added to policy

    • Aldurazyme® (laronidase)
      • Treatment of mucopolysaccharidosis type I (MPS I), including Hurler, Hurler-Scheie, and Scheie forms, in patients age 6 months and older
    • Brineura® (cerliponase alfa)
      • Treatment of late infantile neuronal ceroid lipofuscinosis type 2 (CLN2) in patients age 3 and older
    • Gamifant™ (emapalumab-lzsg)
      • Treatment of adult and pediatric patients with primary hemophagocytic lymphohistiocytosis (HLH)
    • Kanuma® (sebelipase alfa)
      • Treatment of lysosomal acid lipase (LAL) deficiency
    • Naglazyme® (galsulfase)
      • Treatment of mucopolysaccharidosis type VI (MPS VI, also known as Maroteaux-Lamy syndrome), in patients age 3 months and older
    • Sylvant® (siltuximab)
      • Treatment of patients with multicentric Castleman's disease (MCD) in patients age 18 and older

    Gonadotropin Releasing Hormone (GnRH) Analogs, 5.01.625

    New policy

    The following drugs have been added and may be considered medically necessary when criteria are met:

    Breast cancer

    • Zoladex® (goserelin)
      • Palliative treatment of advanced breast cancer in pre- and perimenopausal women

    Central precocious puberty

    • Fensolvi® (leuprolide acetate)
    • Generic leuprolide
    • Lupron Depot PED® (leuprolide acetate)
    • Supprelin LA® (histrelin implant)
    • Triptodur® (triptorelin),
    • Vantas® (histrelin implant)
      • Treatment of children with abnormally early puberty

    Endometriosis

    • Generic leuprolide
    • Lupaneta Pack® (leuprolide/norethindrone)
    • Lupron Depot® (leuprolide acetate)
    • Zoladex® (goserelin)
      • Management of endometriosis, including pain relief and reduction of endometriotic lesions
    • Orilissa® (elagolix)
      • Treatment of moderate to severe pain associated with endometriosis

    Gender dysphoria

    • Fensolvi® (leuprolide acetate)
    • Generic leuprolide
    • Lupron Depot® (leuprolide acetate)
    • Lupron Depot PED® (leuprolide acetate)
    • Supprelin LA® (histrelin implant)
    • Trelstar® (triptorelin pamoate)
    • Triptodur® (triptorelin)
    • Vantas® (histrelin implant)
      • Treatment of gender dysphoria in adolescents

    Prostate cancer

    • Eligard® (leuprolide acetate)
    • Firmagon® (degarelix)
    • Generic leuprolide
    • Lupron Depot® (leuprolide acetate)
    • Orgovyx® (relugolix)
    • Trelstar® (triptorelin pamoate)
    • Zoladex® (goserelin)
      • Palliative treatment of metastatic prostate cancer
    • Zoladex® (goserelin)
      • Treatment of locally confined Stage T2b-T4 (Stage B2-C) prostate cancer when used in combination with flutamide

    Uterine fibroids

    • Generic leuprolide
    • Lupron Depot® (leuprolide acetate)
      • Treatment of anemia due to uterine fibroids
      • To reduce the size of uterine fibroids prior to surgery
    • Oriahnn® (elagolix/estradiol/norethindrone acetate)
      • Management of heavy bleeding related to uterine fibroids in premenopausal patients age 18 and older
    • Zoladex® (goserelin)
      • Use as an endometrial-thinning agent prior to endometrial ablation for abnormal uterine bleeding

    Effective August 6, 2021

    Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570

    Site of service review added
    Vyondys 53® (golodirsen)

    Pharmacotherapy of Cushing’s Disease and Acromegaly, 5.01.548

    New drugs added to policy

    • Bynfezia® Pen (octreotide)
    • Generic octreotide
    • Sandostatin® (octreotide)
    • Sandostatin® LAR Depot (octreotide)
    • Somatuline® Depot (lanreotide)
      • Treatment of acromegaly in adults age 18 and over
      • Treatment of adults with inoperable, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
      • Treatment of adults with carcinoid syndrome
      • Treatment of adults with profuse watery diarrhea associated with vasoactive intestinal peptide tumors (VIPomas)

    Site of Service: Infusion Drugs and Biologic Agents, 11.01.523

    Site of service review added
    Vyondys 53® (golodirsen)

    New medical policies

    Effective June 1, 2021

    Surgical Interruption of Pelvic Nerve Pathways for Chronic Pelvic Pain, 4.01.502

    New policy

    • Uterine nerve ablation or presacral neurectomy for the treatment of chronic pelvic pain is considered investigational

    Revised medical policies

    Effective June 1, 2021

    Colorectal Cancer Screening, 10.01.519

    Coverage statement updated

    • Age range of 50-75 years has been added for preventive screen colonoscopy

    New section added

    • Other covered preventive screening methods, including the following stool-based and direct visualization tests:
      • Fecal immunochemical test (FIT)
      • FIT-DNA test
      • Guaiac-based fecal occult blood test (gFOBT)
      • CT colonography
      • Flexible sigmoidoscopy
      • Flexible sigmoidoscopy with FIT

    Removed from policy

    • List of conditions that are considered not medically necessary for diagnostic colonoscopy

    Electrical Stimulation Devices, 1.01.507

    Investigational criteria updated

    • The following devices are considered investigational for all indications:
      • Electrical sympathetic stimulation therapy
      • Galvanic or high-voltage galvanic stimulation
      • H-wave stimulation
      • Microcurrent electrical nerve stimulation (MENS)
      • Pulsed electrical stimulation and pulsed electromagnetic therapy
      • Remote electrical neuromodulation (REN)
      • Transcutaneous electrical modulation pain reprocessing (TEMPR)
      • Transcutaneous supraorbital electrical nerve stimulator

    Revised pharmacy policies

    Effective June 1, 2021

    Antibody-Drug Conjugates, 5.01.582

    New drug added to policy

    • Zynlonta® (loncastuximab tesirine-lpyl)
    • Treatment of adult patients with relapsed or refractory large B-cell lymphoma

    Immune Checkpoint Inhibitors, 5.01.591

    New drug added to policy

    • Jemperli® (dostarlimab-gxly)
      • Treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer (EC)

    Drugs with new indications

    • Keytruda® (pembrolizumab)
      • First-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
    • Opdivo® (nivolumab)
      • Treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma

    Medical Necessity Criteria for Pharmacy Edits, 5.01.605

    Anticonvulsants

    Medical necessity criteria updated

    • Brand topiramate extended-release capsules
    • Qudexy XR® (topiramate extended-release capsules)
      • The age limit has been reduced from 6 years to 2 years and older for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome

    Atopic Dermatitis

    New drugs added to policy

    • Elidel® (pimecrolimus)
    • Protopic® (tacrolimus)
      • Treatment of atopic dermatitis in patients age 2 and older

    Brand Drugs for ADHD and Stimulants for Other Psychiatric Conditions

    New drug added to policy

    • Qelbree™ (viloxazine extended-release)
      • Treatment of attention deficit hyperactivity disorder (ADHD) in patients age 6 to 17 years of age

    Brand Oral Antibiotics and Their Generics

    New drugs added to policy

    • Omeclamox-Pak® (omeprazole, clarithromycin, amoxicillin)
      • Treatment of Helicobacter pylori infection and duodenal ulcer disease in adults
    • Talicia® (omeprazole, amoxicillin, rifabutin)
      • Treatment of Helicobacter pylori infection in adults

    Brand Oral Antibiotics and Their Generics

    New drugs added to policy

    • Omeclamox-Pak® (omeprazole, clarithromycin, amoxicillin)
      • Treatment of Helicobacter pylori infection and duodenal ulcer disease in adults
    • Talicia® (omeprazole, amoxicillin, rifabutin)
      • Treatment of Helicobacter pylori infection in adults

    Brand Oral Corticosteroids

    New policy section
    New drugs added to policy

    • Alkindi® Sprinkle (hydrocortisone)
    • Cortef® (hydrocortisone)
    • Dxevo® (dexamethasone)
    • Hemady® (dexamethasone)
    • Medrol® (methylprednisolone)
    • Orapred ODT® (prednisolone)
    • Pediapred® (prednisolone)
    • Taperdex® (dexamethasone)
    • Zcort® (dexamethasone)

    Calcium Channel Blockers

    New drugs added to policy

    • Azor® (amlodipine/olmesartan)
    • Caduet® (amlodipine/ atorvastatin)
    • Exforge® (amlodipine/valsartan)
    • Exforge® HCT (amlodipine/valsartan/hydrochlorothiazide)
    • Lotrel® (amlodipine/benazepril)
    • Tarka® (verapamil/trandolapril)
    • Tribenzor® (amlodipine/olmesartan/hydrochlorothiazide)
    • Twynsta® (amlodipine/telmisartan)

    New drug added to policy

    • Prestalia® (amlodipine/perindopril)
      • Treatment of hypertension

    Miscellaneous Oncology Drugs, 5.01.540

    New drugs added to policy

    • Cosela™ (trilaciclib)
      • To decrease chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer
    • Pepaxto® (melphalan flufenamide)
      • Treatment of relapsed or refractory multiple myeloma in patients age 18 and older

    Drugs with new indications

    • Darzalex Faspro™ (daratumumab and hyaluronidase-fihj)
      • Treatment of adult patients with light chain (AL) amyloidosis when used in combination with bortezomib, cyclophosphamide, and dexamethasone as first-line therapy
      • Treatment of adult patients with multiple myeloma when used in combination with bortezomib, thalidomide, and dexamethasone as first-line therapy in patients who are eligible for autologous stem cell transplant
    • Sarclisa® (isatuximab-irfc)
      • Treatment of multiple myeloma when given in combination with Kyprolis® (carfilzomib) and dexamethasone
    • Trodelvy (sacituzumab govitecan-hziy)
      • Treatment of urothelial cancer

    Medical necessity criteria updated

    • Trodelvy (sacituzumab govitecan-hziy)
      • Inoperable locally advanced triple-negative breast cancer has been added to the breast cancer indication

    Pharmacologic Treatment of Idiopathic Pulmonary Fibrosis, 5.01.555

    New drugs added to policy

    • Actemra® (tocilizumab)
      • Treatment of interstitial lung disease associated with systemic sclerosis (SSc-ILD) in patients age 18 and older
    • Tyvaso® (treprostinil)
      • Treatment of pulmonary hypertension associated interstitial lung disease (PH-ILD) in patients age 18 and older

    Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

    New drugs added to policy

    • Kineret® (anakinra)
      • Treatment of deficiency of interleukin-1 receptor antagonist (DIRA)
      • Treatment of cryopyrin-associated periodic syndromes (CAPS)
    • Lupkynis™ (voclosporin)
      • Treatment of adult patients with active lupus nephritis

    Medical necessity criteria updated

    • Benlysta® (belimumab)
      • The requirement of no previous use of Benlysta® (belimumab) in the past 12 months has been removed
      • A requirement has been added that Benlysta® (belimumab) is not used at the same time as Lupkynis™ (voclosporin) for the treatment of active lupus nephritis

    An archived policy is one that's no longer active and is not used for reviews.

    Archived June 1, 2021

    Cardiac Rehabilitation in the Outpatient Setting, 8.03.08

    Keratoprosthesis, 9.03.01

    Outpatient Pulmonary Rehabilitation, 8.03.05

    Deleted June 1, 2021

    No updates this month.

    Added codes

    Effective June 1, 2021

    AIM Specialty Health® Clinical Appropriateness Guidelines for Genetic Testing

    No longer requires review for medical necessity and prior authorization.

    81545

    Keratoprosthesis, 9.03.01

    No longer requires review for medical necessity and prior authorization. Policy archived.

    65770, L8609

    Keratoprosthesis, 9.03.01

    No longer requires review for medical necessity. Policy archived.

    C1818

  • Updates for non-individual plans only

  • No updates this month

    No updates this month

  • Updates for individual plans only

  • Added codes

    Effective September 3, 2021

    The following codes will require review for medical necessity and prior authorization for services on or after September 3, 2021

    American Society of Addiction Medicine (ASAM)

    0362T, 0905, 0912, 97151, 97153, 97154, 97155, 97156, 97158, H0015, H0017, H0035, S9480

    Arthrotomy Hip, InterQual® Criteria

    27269

    Spinal Orthosis, 1.03.502

    L0622, L0623, L0624

    Specialty Rx Non-Oncology Alpha 1- Proteinase Inhibitor, InterQual® Criteria

    J0256

    Surgical Dressings and Wound Care Supplies, 9.01.511

    A6205

    Wound Debridement, InterQual® Criteria

    11008

    See the Special notices section above

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